A Study in People With Abnormal Fat Levels in the Blood

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00116519
First received: June 29, 2005
Last updated: January 24, 2007
Last verified: January 2007

June 29, 2005
January 24, 2007
July 2005
Not Provided
  • Effects on HDL-C and Triglycerides after 12 weeks
  • Safety after 12 weeks
Not Provided
Complete list of historical versions of study NCT00116519 on ClinicalTrials.gov Archive Site
  • Effects on LDL-C after 12 weeks
  • Effects on biomarkers of atherosclerosis after 12 weeks
  • Effects on factors of metabolic syndrome after 12 weeks
Not Provided
Not Provided
Not Provided
 
A Study in People With Abnormal Fat Levels in the Blood
PPAR Alpha: A Phase 2 Dose-Finding and Safety Study for Atherogenic Dyslipidemia by Eli Lilly

The purposes of this study are to determine:

  • The safety of the study medication and any side effects that might be associated with it;
  • Whether the study medication can help patients with low levels of 'good' cholesterol (HDL-C) and high blood fats or triglycerides (TG);
  • How much of the study medication should be given to patients;
  • How the study medication compares to fenofibrate (Lofibra), a drug used for people with low levels of HDL-C and high levels of TG.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Dyslipidemia
  • Drug: PPAR alpha
  • Drug: placebo
Not Provided
Nissen SE, Nicholls SJ, Wolski K, Howey DC, McErlean E, Wang MD, Gomez EV, Russo JM. Effects of a potent and selective PPAR-alpha agonist in patients with atherogenic dyslipidemia or hypercholesterolemia: two randomized controlled trials. JAMA. 2007 Mar 28;297(12):1362-73. Epub 2007 Mar 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
October 2006
Not Provided

Inclusion Criteria:

  • Men and women between 18 and 80 years of age
  • People with abnormal fat levels in the blood (low HDL, high TG)

Exclusion Criteria:

  • People with diabetes
  • People whose blood pressure is greater than 160/95 mm Hg, on or off blood pressure medicine
  • People who have had frequent chest pain or unstable angina, a heart attack or a heart procedure, including stent placement, within the past 3 months
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00116519
5750, H8D-MC-EMBB
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday - Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP